Eli Lil­ly picks up an­oth­er Covid-19 EUA as reg­u­la­tors wave through its Olu­mi­ant plus remde­sivir com­bo

Eli Lil­ly has picked up an­oth­er win at the FDA, cross­ing the fin­ish line again in the Covid-19 treat­ment race de­spite some mixed da­ta. And the au­tho­riza­tion comes be­fore Re­gen­eron’s an­ti­body ther­a­py, which no­tably was used to treat Pres­i­dent Don­ald Trump back in Oc­to­ber, could pick up an EUA.

Reg­u­la­tors have giv­en the green light to Lil­ly’s Olu­mi­ant, in com­bi­na­tion with Gilead’s remde­sivir, to treat sus­pect­ed or con­firmed Covid-19 cas­es in both hos­pi­tal­ized adults and chil­dren over 2 that need sup­ple­men­tal oxy­gen, ven­ti­la­tors or life sup­port. The au­tho­riza­tion was based on da­ta show­ing the me­di­an time to re­cov­ery from Covid-19 was sev­en days on the com­bo vs. eight days for remde­sivir by it­self.

“Based on the FDA’s re­view of the to­tal­i­ty of the sci­en­tif­ic ev­i­dence avail­able, the agency has de­ter­mined that it is rea­son­able to be­lieve that baric­i­tinib, in com­bi­na­tion with remde­sivir, may be ef­fec­tive in treat­ing Covid-19 for the au­tho­rized pop­u­la­tion,” the FDA said in a state­ment.

A Lil­ly spokesper­son con­firmed to End­points News that the cock­tail will cost hos­pi­tals $150 per pa­tient per day for those with in­sur­ance.

Lil­ly re­vealed the da­ta back in Sep­tem­ber, defin­ing re­cov­ery as meet­ing the cri­te­ria for hos­pi­tal dis­charge. They fol­lowed up in Oc­to­ber say­ing the p-val­ue was 0.047, with the ben­e­fits be­ing most pro­nounced among pa­tients need­ing sup­ple­men­tal oxy­gen or non-in­va­sive ven­ti­la­tion at base­line.

The EUA comes amid broad­er ques­tions re­gard­ing remde­sivir’s ef­fec­tive­ness. No­tably, a WHO tri­al showed the an­tivi­ral didn’t have any sub­stan­tial ef­fect on im­prov­ing mor­tal­i­ty rates, re­duc­ing the amount of pa­tients need­ing ven­ti­la­tors or short­en­ing hos­pi­tal stays.

The FDA is­sued a full ap­proval for remde­sivir in late Oc­to­ber on the ba­sis of a sep­a­rate tri­al, where the drug had “mod­er­ate­ly re­duced time to re­cov­ery.” That study, the NI­AID-spon­sored Phase III ACTT-1 tri­al pub­lished on Oct 8, demon­strat­ed a re­duc­tion in re­cov­ery time by five days in hos­pi­tal­ized Covid-19 pa­tients and by sev­en days in pa­tients re­quir­ing oxy­gen.

Reg­u­la­tors did con­sid­er the WHO tri­al in its de­ci­sion to ap­prove remde­sivir, but said since Gilead’s ACTT-1 study was ran­dom­ized, dou­ble-blind­ed and place­bo-con­trolled where­as the WHO tri­al was open-la­bel, they found ACTT-1 to be “bet­ter suit­ed” in a time to re­cov­ery end­point.

Olu­mi­ant, al­so known as baric­i­tinib, is a JAK in­hibitor used to treat rheuma­toid arthri­tis, net­ting Eli Lil­ly near­ly $450 mil­lion through the first three quar­ters of 2020. It was the first drug the NIH test­ed in com­bi­na­tion im­me­di­ate­ly af­ter fin­ish­ing the remde­sivir tri­al.

This is the sec­ond EUA Lil­ly has re­ceived in as many weeks, with reg­u­la­tors au­tho­riz­ing one of the com­pa­ny’s neu­tral­iz­ing an­ti­body treat­ments less than ten days ago. Both Lil­ly and Re­gen­eron, which is de­vel­op­ing its own an­ti­body treat­ment, re­vealed they ap­plied for those EUAs on the same day.

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